103836 Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Food Labeling: Notification Procedures 

for Statements on Dietary 

Supplements—21 CFR 101.93 

OMB Control Number 0910–0331— 

Extension 

Section 403(r)(6) of the FD&C Act (21 

U.S.C. 343(r)(6)) and § 101.93 (21 CFR 

101.93) require that, no later than 30 

days after the first marketing, we be 

notified by the manufacturer, packer, or 

distributor of a dietary supplement that 

it is marketing a dietary supplement 

product that bears on its label or in its 

labeling a statement provided for in 

section 403(r)(6) of the FD&C Act. In 

accordance with these requirements, 

submissions must include: (1) the name 

and address of the manufacturer, 

packer, or distributor of the dietary 

supplement product; (2) the text of the 

statement that is being made; (3) the 

name of the dietary ingredient or 

supplement that is the subject of the 

statement; (4) the name of the dietary 

supplement (including the brand name); 

and (5) the signature of a responsible 

individual or the person who can certify 

the accuracy of the information 

presented, and who must certify that the 

information contained in the notice is 

complete and accurate, and that the 

notifying firm has substantiation that 

the statement is truthful and not 

misleading. 

Our electronic form (Form FDA 3955) 

allows respondents to the information 

collection to electronically submit 

notifications to FDA via the Food 

Applications Regulatory Management 

(FARM) system. Firms that prefer to 

submit a paper notification in a format 

of their own choosing still have the 

option to do so; however, Form FDA 

3955 prompts respondents to include 

certain elements in their structure/ 

function claim notification (SFCN) 

described in § 101.93 in a standard 

electronic format and helps respondents 

organize their SFCN to include only the 

information needed for our review of 

the claim. Note that the SFCN, whether 

electronic or paper, is used for all 

claims made pursuant to section 

403(r)(6) of the FD&C Act, including 

nutrient deficiency claims and general 

well-being claims in addition to 

structure/function claims. The 

electronic form, and any optional 

elements prepared as attachments to the 

form (e.g., label), can be submitted in 

electronic format via FARM. 

Submissions of SFCNs will continue to 

be allowed in paper format. We use this 

information to evaluate whether 

statements made for dietary ingredients 

or dietary supplements are permissible 

under section 403(r)(6) of the FD&C Act. 

We also provide information on our 

website at https://www.fda.gov/food/ 

information-industry-dietarysupplements/notificationsstructurefunction-and-related-claimsdietary-supplement-labeling, which may 

serve as a helpful resource to 

respondents. 

Description of Respondents: 

Respondents to this collection of 

information include manufacturers, 

packers, or distributors of dietary 

supplements that bear section 403(r)(6) 

of the FD&C Act statements on their 

labels or labeling. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity; form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

Total 

hours 

101.93; Statements for Dietary Supplements; Form FDA 

3955.

3,690 1 3,690 0.75 (45 minutes) .. 2,768 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

This estimate is based on our experience 

with this information collection and the 

number of notifications received in the 

past 3 years, which has remained 

constant. 

Dated: December 12, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–30231 Filed 12–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3379] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Laboratory 

Accreditation for Analyses of Foods 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 21, 

2025. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 


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Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 103837 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0898. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Laboratory Accreditation for Analysis 

of Foods 

OMB Control Number 0910–0898— 

Extension 

This information collection helps to 

support implementation of FDA’s 

statutory and regulatory authority 

governing our laboratory accreditation 

for analysis of foods program under 

section 422 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 350k) and 

21 CFR part 1, subpart R. FDA has 

statutory authority to establish a 

program for the testing of food by 

accredited laboratories; to establish a 

publicly available registry of recognized 

accreditation bodies and laboratories 

recognized by an accreditation body; 

and to require reports of any changes 

that would affect the recognition of such 

accreditation body or the accreditation 

of such laboratory. 

The regulations require respondents 

to maintain and electronically submit 

certain test results, reports, 

notifications, and other records to FDA. 

We are clarifying that the information 

collection includes the use of an 

electronic information collection system 

(the FURLS Laboratory Accreditation for 

Analyses of Foods Program portal) (FDA 

Industry Systems). User guides for the 

Accreditation Bodies and Accredited 

Laboratories can be found at the 

following links: https://www.fda.gov/ 

media/156097/download?attachment 

and https://www.fda.gov/media/161685/ 

download?attachment. The laboratory 

accreditation program helps fulfill 

FDA’s mandate to ensure the safety of 

the U.S. food supply and protect U.S. 

consumers by administering appropriate 

oversight of certain food testing that is 

of importance to public health. It also 

helps ensure that the testing is done in 

accordance with appropriate model 

standards, which will help produce 

consistently reliable and valid test 

results. You may access additional 

information about the laboratory 

accreditation program at: https://

www.fda.gov/food/food-safetymodernization-act-fsma/fda-recognizedaccreditation-bodies-laboratoryaccreditation-analyses-foods-laafprogram. The public registry is available 

at https://datadashboard.fda.gov/ora/ 

fd/laaf.htm. 

Respondents to the information 

collection are accreditation bodies 

seeking recognition from FDA, 

recognized accreditation bodies, 

laboratories seeking accreditation from 

recognized accreditation bodies, and 

accredited laboratories. Participation in 

this program is voluntary for 

laboratories and accreditation bodies; 

however, only recognized accreditation 

bodies would be able to accredit 

laboratories to conduct food testing as 

specified in the regulations. 

In the Federal Register of August 15, 

2024 (89 FR 66417), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 2

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

§§ 1.1113 and 1.1114; Accreditation bodies (ABs) 

application for recognition (one-time submission).

8 44 352 2.2068 (2 hours and 

12 minutes).

776.8 

§§ 1.1113 and 1.1114; ABs—application for renewal 

of recognition.

§ 1.1123; ABs—reports, notifications, and documentation requirements.

§ 1.1116(a) and (b); ABs—notices of intent to relinquish, records custodian.1 3 3 3 .............................. 9 

§§ 1.1138 and 1.1139; laboratories—submission of 

application for LAAF-accreditation (one-time submission).

160 63.5 10,160 1.8051 (1 hour and 

49 minutes).

18,340 

§§ 1.1149(a) and 1.1152(c)(1), (2); laboratories— 

submission of sampling plan, sample collection report, and sampler qualifications.

§§ 1.1152(d) and 1.1153(a); laboratories—qualification to submit abridged analytical reports (onetime submission).

§ 1.1153; laboratories—abridged analytical reports 

submissions.

§ 1.1149(c); laboratories—advance notice of sampling submissions.

§ 1.1152(f); laboratories—immediate notification.

§ 1.1140(a); laboratories—notices of intent to relinquish, records custodian.2 3 6 1 .............................. 6 

§ 1.1152(c)(4) and (5); laboratories—validation and 

verification studies submissions.

50 5 250 1.5 (1 hour and 30 

minutes).

375 

§§ 1.1142; 1.1171; 1.1173; and 1.1174; requests in 

response to FDA action.

1 1 1 1 .............................. 1 

Total .................................................................... ........................ ........................ 10,772 ................................. 19,508 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


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103838 Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices 

2Totals may not sum due to rounding. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 2

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

§ 1.1113; recordkeeping associated with ISO/IEC 

17011:2017.

8 2 8 22 ............................ 176 

§ 1.1124; ABs—additional recordkeeping requirements a recognized accreditation body must 

maintain, for 5 years after the date of creation of 

the records, records created while it is recognized 

demonstrating its compliance with this subpart.

§ 1.1138; laboratories—becoming accredited to ISO/ 

IEC 17025:2017 (one-time); Laboratories adding 

ISO 17025 to become LAAF-accredited.

9 1 9 91.06 (91 hours and 

4 minutes).

820 

§ 1.1138; laboratories—maintaining ISO/IEC 17025: 

2017 accreditation.

160 2 320 450.765 (450 hours 

and 46 minutes).

144,245 

§ 1.1154; laboratories—additional recordkeeping requirements; a LAAF-accredited laboratory must 

maintain, for 5 years after the date of creation, 

records created and received while it is LAAF-accredited that relate to compliance with this subpart.

Total .................................................................... ........................ ........................ 345 ................................. 145,241 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Totals may not sum due to rounding. 

The burden we attribute to reporting 

and recordkeeping activities is assumed 

to be distributed among the individual 

elements of the respective information 

collection activities. Although we have 

not received a notice of intent to 

relinquish records since the last 

approval of this information collection, 

we include one response for the purpose 

of estimating burden. 

We calculate the number of food 

testing laboratories seeking 

accreditation based on the number of 

applicants. As a result, the number of 

respondents to the information 

collection decreased (from 170 

respondents in the currently approved 

collection to 160 respondents). 

Consequently, we have adjusted our 

burden estimate, which results in a 

decrease of 227 responses and 9,303 

burden hours from the currently 

approved information collection. 

Dated: December 11, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–30230 Filed 12–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5581] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Additives 

Intended for Use in Animal Food, Food 

Additive Petitions, Investigational 

Food Additive Files Exemptions, and 

Declaration on Animal Food Labels 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions associated with 

food additives intended for use in 

animal food, food additive petitions, 

investigational food additive files 

exemptions, and declaration of color 

additives on animal food labels. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

February 18, 2025. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 18, 2025. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 


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